This information is intended for US healthcare professionals to access current scientific information about J&J Innovative Medicine products. It is prepared by Medical Information and is not intended for promotional purposes, nor to provide medical advice.
SUMMARY
- Please refer to local labeling for information regarding formulations and/or dosage strengths.
Solution for Subcutaneous Injection, Single-Use Prefilled Syringe
STELARA 45 mg/0.5 mL or STELARA 90 mg/mL
- The needle cover on the prefilled syringe contains dry natural rubber (a derivative of latex), which may cause allergic reactions in individuals sensitive to latex.1,2
- The excipients of the prefilled syringe are not made with natural rubber latex, but we cannot guarantee that the excipients do not come in contact with latex during the manufacturing or packaging process (eg, latex gloves).1
Solution for subcutaneous injection, one-press patient-controlled injector/prefilled pen
STELARA 45 mg/0.5 mL or STELARA 90 mg/mL
- The needle cover inside the bottom cap of the One-Press injector/prefilled pen contains dry natural rubber (a derivative of latex), which may cause allergic reactions in individuals sensitive to latex.2,3
- The excipients of the One-Press injector/prefilled pen are not made with natural rubber latex, but we cannot guarantee that the excipients do not come in contact with latex during the manufacturing or packaging process (eg, latex gloves).3
Solution for Subcutaneous Injection, Single-Use Vial
STELARA 45 mg/0.5 mL
- The immediate container or excipients of the STELARA 45 mg/0.5 mL single-use vial are not made with natural rubber latex. However, we cannot guarantee that the excipients do not come in contact with latex during the manufacturing or packaging process (eg, latex gloves).1
Solution for Intravenous Infusion, Single-Use Vial
STELARA 130 mg/26 mL (5 mg/mL)
- The immediate container or excipients of the STELARA 130 mg/26 mL (5 mg/mL) single-use vial are not made with natural rubber latex. However, we cannot guarantee that the excipients do not come in contact with latex during the manufacturing or packaging process (eg, latex gloves).4
1 | Data on File. Technical Document Patient Safety and Compliance Information for STELARA 45 mg/0.5 mL injectable solution in vials (FVP) and 45 mg/0.5 mL (or 90 mg/mL) injectable solution in prefilled syringes (PFS) v6. Janssen Research and Development, LLC; 2024. |
2 | Data on File. Ustekinumab Company Core Data Sheet v52. Janssen Research & Development, LLC. EDMS-ERI-22004273; 2024. |
3 | Data on File. Latex Assessment of Stelara One-Press Injector v1. Janssen Research and Development, LLC; 2023. |
4 | Data on File. Technical Document Patient Safety and Compliance Information for STELARA FVP IV 5 mg/mL v4. Janssen Research and Development, LLC; 2024. |